NCT03849404已完成3 期
A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 30
- 主要终点
- Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.
详细描述
A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS).
This study will be conducted at about 40 study centers in central and eastern European countries. A contract research organization, will oversee operational aspects of this study on behalf of Alvotech Swiss AG (Alvotech), the Sponsor of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double blind study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with moderate-to-severe chronic plaque psoriasis who has involved body surface area (BSA) ≥ 10% (Palm Method), ≥ 12 on the PASI, and static Physicians Global Assessments (sPGA) ≥ 3 (moderate) at Screening and at BL.
- •Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
- •Patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB).
排除标准
- •Patient has prior use of 2 or more biologics for treatment of PsO.
- •Patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), or other systemic autoimmune disorder inflammatory disease at the time of the Screening visit that would interfere with evaluations of the effect of the study drug on psoriasis.
- •Patient has prior use of any of the following medications within specified time periods or will require use during the study:
- •Topical medications within 2 weeks of BL (Week 1).
- •PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit.
- •Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the BL Visit.
- •Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational.
- •Any systemic steroid in the 4 weeks prior to BL.
- •Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened and randomized per the list in the protocol
结局指标
主要结局
Psoriasis Area and Severity Index (PASI)
时间窗: Baseline to Week 16
Percent (%) change in Psoriasis Area and Severity Index (PASI)
次要结局
- Psoriasis Area and Severity Index (PASI)(Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50)
研究者
研究点 (30)
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